Regulation (EU) 2019/4 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER I U.K. SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 U.K. Subject matter

This Regulation lays down specific provisions regarding medicated feed and intermediate products, which are additional to Union legislation on feed and apply without prejudice in particular to Regulations (EC) No 1831/2003, (EC) No 183/2005 and (EC) No 767/2009 and Directive 2002/32/EC.

Article 2 U.K. Scope

1. This Regulation applies to:

(a) the manufacture, storage and transport of medicated feed and intermediate products;

(b) the placing on the market, including import from third countries, and use of medicated feed and intermediate products;

(c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 16, 17 and 18 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.

2. This Regulation does not apply to veterinary medicinal products as defined in Regulation (EU) 2019/6 except where such products are included in a medicated feed or an intermediate product.

Article 3 U.K. Definitions

1. For the purposes of this Regulation, the following definitions apply:

(a) the definitions of ‘feed’, ‘feed business’ and ‘placing on the market’ as laid down, respectively, in points 4, 5 and 8 of Article 3 of Regulation (EC) No 178/2002;

(b) the definitions of ‘feed additives’ and ‘daily ration’ as laid down, respectively, in points (a) and (f) of Article 2(2) of Regulation (EC) No 1831/2003;

(c) the definitions of ‘food-producing animal’, ‘non-food-producing animals’, ‘fur animals’, ‘feed materials’, ‘compound feed’, ‘complete feed’, ‘complementary feed’, ‘mineral feed’, ‘minimum storage life’, ‘batch’, ‘labelling’ and ‘label’ as laid down, respectively, in points (c), (d), (e), (g), (h), (i), (j), (k), (q), (r), (s) and (t) of Article 3(2) of Regulation (EC) No 767/2009;

(d) the definition of ‘establishment’ as laid down in point (d) of Article 3 of Regulation (EC) No 183/2005;

(e) the definitions of ‘official controls’ and ‘competent authorities’ as laid down, respectively, in Article 2(1) and in point 3 of Article 3, of Regulation (EU) 2017/625;

(f) the definitions of ‘veterinary medicinal product’, ‘active substance’, ‘immunological veterinary medicinal product’, ‘antimicrobial’, ‘antiparasitic’, ‘antibiotic’, ‘metaphylaxis’, ‘prophylaxis’, and ‘withdrawal period’, as laid down, respectively, in points 1, 3, 5, 12, 13, 14, 15, 16 and 34 of Article 4 of Regulation (EU) 2019/6, and ‘summary of the product characteristics’ referred to in Article 35 of that Regulation.

2. The following definitions also apply:

(a) ‘medicated feed’ means a feed, which is ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products or intermediate products with feed materials or compound feed;

(b) ‘intermediate product’ means a feed, which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products with feed materials or compound feed, exclusively intended to be used for the manufacture of medicated feed;

(c) ‘non-target feed’ means feed, whether medicated or not, which is not intended to contain a specific active substance;

(d) ‘cross-contamination’ means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment;

(e) ‘feed business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under that person’s control;

(f) ‘mobile mixer’ means a feed business operator with a feed establishment consisting of a specifically equipped vehicle for the manufacture of medicated feed;

(g) ‘on-farm mixer’ means a feed business operator manufacturing medicated feed for the exclusive use on its farm;

(h) ‘veterinary prescription for medicated feed’ means a document issued by a veterinarian for a medicated feed;

(i) ‘advertising’ means the making of a representation in any form in connection with medicated feed and intermediate products in order to promote prescription or use of medicated feed comprising also the supply of samples and sponsorships;

(j) ‘animal keeper’ means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis.